Article preview from Start-Up - June, 2012
Early last year, Sonitus Medical obtained 510(k) notification for its non-surgical hearing assistance device to be used in patients with single-sided deafness. The culmination of five years of work, the FDA clearance positioned Sonitus to compete in, and company officials hope ultimately to expand, the $100 million market for devices for conductive hearing loss. But to do that effectively, the company still needs to convince Centers for Medicaid and Medicare Services and private payors.
Article preview from Start-Up - June, 2012
One venture capitalist likens the pursuit of Food and Drug Administration approval for a medical device to climbing a mountain. A company grunts, grabs, pulls and scrambles to the top, expecting to enjoy a clear vista to the horizon. But once they stand astride the summit they can only eye an even higher peak – obtaining the necessary codes for reimbursement by payors. Hearing assistance device company Sonitus Medical Inc. finds itself standing atop the first peak. Early last year, the company obtained 510(k) notification for its non-surgical hearing assistance device to be used in patients with single-sided deafness. The culmination of five years of work, the FDA approval positioned Sonitus to compete in – and company officials hope ultimately to expand – the $100 million market for devices for conductive hearing loss. But to do that effectively, the company still needs to convince the Centers for Medicaid and Medicare Services and private payors.
Obtaining reimbursement shouldn’t be difficult. Sonitus moves into the established market for conductive hearing devices – which transmit sound through vibrations of the bone rather than merely amplifying noise. Its SoundBite system will offer patients with single-sided deafness a nearly zero-invasive option to current devices. Such devices, like the Baha 3, a conductive hearing assistance device sold by Cochlear Ltd., require users to have a screw surgically driven into their jaw. Relatively speaking, the procedure isn’t invasive as other surgeries. But Sonitus goes one step further. Instead of requiring a screw as a point of contact, the SoundBite utilizes a patient’s own teeth. The system employs a customized dental ITM (in-the-mouth) piece, which is made to fit around either the upper left or right back teeth. The wearer places and removes the ITM and accompanying ear piece whenever necessary.
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